A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain
Phase 4
Completed
- Conditions
- Brain Pathology
- Registration Number
- NCT00323102
- Lead Sponsor
- Bracco Diagnostics, Inc
- Brief Summary
This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
- 18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days
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Exclusion Criteria
- Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Superiority of Multihance in terms of by-patient global diagnostic performance immediately post dose
- Secondary Outcome Measures
Name Time Method To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions immediately post dose To compare the two products in terms of global changes in lesion count; To compare the two products in terms of changes from pre to post dose in signal intensity immediately post dose
Trial Locations
- Locations (1)
Bracco Diagnostics, Inc.
🇺🇸Princeton, New Jersey, United States